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United States · US · US:72162-2020_4bc4698c-3d3c-e862-e063-6394a90a142f

ORPHENADRINE CITRATE

Orange BookUNIISPLATC M03BC01

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC codeM03BC01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    7216220201
    100 TABLET, EXTENDED RELEASE in 1 BOTTLE (72162-2020-1)
  • ndc11
    7216220205
    500 TABLET, EXTENDED RELEASE in 1 BOTTLE (72162-2020-5)
  • ndc11
    7216220206
    60 TABLET, EXTENDED RELEASE in 1 BOTTLE (72162-2020-6)

Annotations

UNII (FDA Substance ID)
X0A40N8I4S
ORPHENADRINE CITRATE
RxCUI 7716
Orange Book
A040284
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "X0A40N8I4S",
    "rxcui": "7716",
    "inchikey": "MMMNTDFSPSQXJP-UHFFFAOYSA-N",
    "display_name": "ORPHENADRINE CITRATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "7905e80f-b60b-48e8-8e63-a3e50211bfe4": {
      "match": "brand_token",
      "title": "ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [REMEDYREPACK INC.]",
      "spl_version": "3",
      "published_date": "2026-04-30"
    }
  },
  "productid": "72162-2020_4bc4698c-3d3c-e862-e063-6394a90a142f",
  "productndc": "72162-2020",
  "dosage_form": "TABLET, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "040284",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "001",
        "approval_date": "Jun 19, 1998"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ORPHENADRINE CITRATE",
  "proprietary_name": "ORPHENADRINE CITRATE",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA040284",
  "marketing_category": "ANDA",
  "nonproprietary_name": "ORPHENADRINE CITRATE",
  "start_marketing_date": "19980619",
  "active_numerator_strength": "100"
}

Related drugs

Other records sharing ATC code M03BC01.

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